Steinhart 2002.
| Methods | Randomized, placebo controlled with blinded investigators Intention to treat not performed Eight week trial |
|
| Participants | Patients aged 14 years or older with active CD (CDAI 200‐400) (N = 134) | |
| Interventions | Patients were randomised to receive oral ciprofloxacin 500 mg BID and oral metronidazole 500 mg BID (n = 66) or oral placebo (n = 68) All patients received oral budesonide 9 mg once daily |
|
| Outcomes |
Primary outcome:The number of patients in remission at week 8, defined by CDAI < 150 Secondary outcomes: The mean changes in scores on the CDAI, quality of life, and adverse drug reactions |
|
| Notes | Patients were 14 years and older | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated randomisation |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Investigators and participants were blinded to treatment assignment Double blind: identical placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators were unaware of treatment assignments |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Sixteen patients in the placebo group and 22 patients in the antibiotic group did not complete the treatment course |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |